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A Study to Evaluate the Effects of Multiple Doses of FG-4592 on the Exposure, Safety and Tolerability and Effect of Warfarin in Healthy Subjects

NCT02252731 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2014-09-30

No results posted yet for this study

Summary

This study will determine the effect of multiple doses of FG-4592 on the pharmacokinetics (PK) of a single dose of warfarin. It will evaluate the safety and tolerability of warfarin alone and in combination with multiple doses of FG-4592, and will evaluate the effect of multiple doses of FG-4592 on the pharmacodynamics (PD) of warfarin.

Conditions

  • Pharmacokinetics of FG-4592
  • Healthy Subjects

Interventions

DRUG

Warfarin

Oral

DRUG

FG-4592

Oral

Sponsors & Collaborators

  • FibroGen

    collaborator INDUSTRY

  • Astellas Pharma Europe B.V.

    lead INDUSTRY

Principal Investigators

  • Study Physician · Astellas Pharma Europe B.V.

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02252731 on ClinicalTrials.gov